Kids in CA Trials Lack Understanding of Research

Action Points

Explain to interested patients that this study suggests that increased efforts are needed to enhance children's understanding of participation in oncology trials.

Although it is federally mandated, obtaining children's assent to participate in clinical trials does not appear to ensure that they understand what that means, researchers found.

Among children participating in oncology trials, 41% said they did not know specific purpose of the study, Yoram Unguru, MD, of Herman and Walter Samuelson Children's Hospital at Sinai in Baltimore, and colleagues reported in the April issue of Pediatrics.

Of those who said they did know the purpose of the study, only 22% correctly defined it.

In addition, about half of the children (49%) felt like they had little, very little, or no role in the decision to take part in the trial, despite signing the assent forms.

"Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful," Unguru and colleagues concluded.

The next step, they said, is developing such a tool.

Most children with cancer are enrolled in clinical trials, and the U.S. Department of Health and Human Services requires that children give their assent whenever possible.

However, previous studies of children's understanding have mainly involved healthy youngsters using hypothetical scenarios, or they focused on decision-making preferences of adolescents, according to the researchers.

To further explore the issue, Unguru and his colleagues interviewed 37 children and teens ages 7 to 19 (mean 13.6) who were taking part in various oncology trials. The researchers used a novel, 69-item quality-of-assent instrument that the children read as they were asked the questions verbally.

Only about half of the children remembered being told their treatment was research, even though 87% remembered hearing the word "research" and 95% remembered hearing the word "study" from their doctors.

In general, the children had a poor understanding of the purpose of their respective trials, with 70% saying it was a little or very hard to understand information about the trial when they assented.

The vast majority (86%) said they did not understand the language their doctor used.

Most of the children did not understand the nature of their treatment, with 73% saying they thought research interventions were not more risky than other interventions and that the medications they were receiving were proven to be the best for their condition.

Responding to questions meant to assess the children's appreciation of the goals of research, 73% said they were participating in the trial to help other children, 60% said they were taking part to get better, and 43% said they were helping doctors expand their knowledge.

All of the children said they wanted to have at least some part in deciding to participate in the trial, while 97% said they wanted their parents involved, and 94% said they wanted their doctors involved.

However, about half felt largely excluded from the decision-making process, and 38% did not feel like they could decline to participate, citing pressure from parents, doctors, or both.

"Our findings suggest that parents/physicians could do more to involve children in decision-making to avoid forcing them to enroll in trials," the researchers wrote.

They acknowledged some limitations of the study, including the small sample, the possibility that the children's responses reflected what they thought the researchers wanted to hear, the possibility of bias from recalling past events, and the confusion some children had about the difference between clinical care and clinical research.

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.